Medical device and in vitro diagnostic device manufacturers operate in an environment which is highly regulated. To market their devices on international markets, they need to comply with the regulations existing in each and every country. These often include the requirement for specific related content to be available in the native language of the speakers in the given market.
Learn about how Moravia helps producers reach international markets and about the complete portfolio of key services that are customized for the life sciences industries.
International Regulatory Compliance
In the European Union, for instance, manufacturers must obtain the pre-market CE mark compliance label for their products, and to otherwise make sure they meet the requirements of applicable directives. These include the Medical Devices Directive (MDD) (Directive 93/42/EEC), the Active Implantable Medical Devices Directive (AIMDD) (Directive 90/385/EEC), and the In Vitro Diagnostic Directive (IVDD) (Directive 98/79/EC). In individual European countries, specific national laws may also need to be considered.
Similar situation exists in other markets, be it those that form part of the Global Harmonization Task Force (GHTF) (Australia, Canada, Japan, and the USA, complementing the EU), or the many nations that are outside the EU and GHTF, such as China, with regulations set by the Chinese State Food and Drug Administration (SFDA), Russia and Brazil.
Key Related Directives and Regulations
Medical Devices Directive (MDD)
Active Implantable Medical Devices (AIMDD)
In Vitro Diagnostic Directive (IVDD)
Managing regulatory compliance is one of the most critical aspects for medical device companies to deal with. Even a minor mistake can delay regulatory approval and push back a product launch.
Quality errors in translations - in addition to generating extra costs for correction - can also result in product delays, product recalls, and in some cases can even lead to product liability lawsuits.
All this puts an additional responsibility on managers at medical companies as they choose their translation services providers.
Solutions for the Complete Medical Device Product Lifecycle
At Moravia we realize the importance of providing you with a dependable and comprehensive solution, which allows you to focus on the product, while we take care of your language needs. Moravia Worldwide has the expertise to provide you with the infrastructure for achieving faster time-to-market and high quality translations, throughout the complete medical device product lifecycle:
- Pre-market Translation of documents related to conception and development, manufacture, packaging and labeling of medical devices, as well as clinical trials and regulatory clearance and approval documentation.
- Placing on-market Localization of materials for advertising and sale of products on international markets, including your internal training materials.
- Postmarketing surveillance/vigilance Translation of the wide range of materials related to the safe use and ultimate disposal of medical devices.